For the first time ever, a Cannabidiol-based product has been approved in India delivering a unique therapy option for those with neurological disorders. The product is being manufactured at USFDA and EU approved state-of-the-art facilities in Hyderabad and Visakhapatnam, said Hyderabad-based Biophore India Pharmaceuticals on Monday.
It announced that it has received approval from the Central Drugs Standard Control Organisation(CDSCO) for manufacturing and marketing of Cannabidiol in India. However, Cannabidiol by Zenara and Biophore has been filed with the USFDA and is awaiting approval.
In a statement here, the drug maker Biophore India Pharmaceuticals said that its subsidiary Zenara Pharma has received approval for the final product, Cannabidiol Oral Solution 100mg/ml for use in neurological disorders.
Cannabidiol or CBD, is the active ingredient in the cannabis or hemp plant, and some form of CBD is used for therapeutic purposes for certain medical conditions. This is the first time ever that a Cannabidiol-based product has been approved in India delivering a unique therapy option, it said.
The approval currently received is for the treatment of seizures associated with Lennox-Gastaut syndrome, Dravet syndrome or tuberous sclerosis complex in patients 1 year of age or older.